The Effect of Mannitol Volume with Changes in Osmolarity in Traumatic Brain Injury

Last updated: February 26, 2025
Sponsor: Universitas Diponegoro
Overall Status: Completed

Phase

3

Condition

Traumatic Brain Injury

Neurologic Disorders

Memory Loss

Treatment

Mannitol

Clinical Study ID

NCT06846307
1554/EC/KEPK-RSDK/2023
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This observational study is designed to research the effect of mannitol volume administration with changes in osmolarity in patients with traumatic brain injury to guide the safe use of mannitol in these patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18-40 years

  • Glasgow Coma Scale (GCS) score indicating mild (14-13) or moderate (12-10)

Exclusion

Exclusion Criteria:

  • Renal impairment

  • Multiple trauma with bleeding shock

  • Diabetes mellitus

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Mannitol
Phase: 3
Study Start date:
November 01, 2023
Estimated Completion Date:
January 31, 2024

Study Description

This study used an analytic observational design with a prospective cohort approach to evaluate the relationship between mannitol administration volume and changes in osmolarity in TBI patients at Dr. Kariadi Central General Hospital, Semarang, Indonesia. The study included 32 non-operative TBI patients admitted to the Emergency Department (ED) and inpatient wards from November 2023 to January 2024. Samples were selected using a consecutive sampling method based on the inclusion criteria. The independent variable in this study was the volume of mannitol administered (3x125 cc, 2x250 cc, 3x250 cc; each 250 cc contains 50g mannitol) given as an IV drip for 15-20 minutes, while the dependent variable was blood osmolarity (mOsm/L).

Connect with a study center

  • Dr. Kariadi Central General Hospital

    Semarang, Central Java
    Indonesia

    Site Not Available

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